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 Department of Health and Human Services Agency for Healthcare Research and Quality
 AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
 ACTION: Request for supplemental evidence and data submission.
 SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on 
                        *Systematic Review—Interventions to Improve Care of Bereaved Persons,*
                         which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
 DATES: *Submission Deadline*
                         on or before January 11, 2024.
 ADDRESSES:  *Email submissions: epc@ahrq.hhs.gov.* *Print submissions:* *Mailing Address:*
                         Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. *Shipping Address (FedEx, UPS, etc.):*, Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857.
 FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656 or Email: 
                        *epc@ahrq.hhs.gov.*


SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for 
                    *Systematic Review—Interventions to Improve Care of Bereaved Persons.*
                     AHRQ is conducting this review pursuant to section 902 of the Public Health Service Act, 42 U.S.C. 299a. The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (
                    *e.g.,*
                     details of studies conducted). We are looking for studies that report on 
                    *Systematic Review—Interventions to Improve Care of Bereaved Persons.*
                     The entire research protocol is available online at: 
                    *https://effectivehealthcare.ahrq.gov/​products/​bereaved-persons/​protocol.* This is to notify the public that the EPC Program would find the following information on 
                    *Systematic Review—Interventions to Improve Care of Bereaved Persons*
                     helpful: A list of completed studies that your organization has sponsored for this topic. In the list, please 
                    *indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.* *For completed studies that do not have results on ClinicalTrials.gov,*
                     a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results. *A list of ongoing studies that your organization has sponsored for this topic.*
                     In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. Description of whether the above studies constitute 
                    *ALL Phase II and above clinical trials*
                     sponsored by your organization for this topic and an index outlining the relevant information in each submitted file. Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in 
                    ( print page 86138)
                    the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: 
                    *https://www.effectivehealthcare.ahrq.gov/​email-updates.* *The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.* Key Questions (KQ) *Key Question 1:*
                     What is the effectiveness and harms of universally screening people for bereavement and response to loss? a. 
                    *Timing:*
                     predeath, acute, or 6-12 months post loss, and more than 1 year post loss? b. Does effectiveness vary by patient characteristic or setting? *Key Question 2:*
                     How accurate are tools to identify bereaved persons at risk for or with grief disorders? *Key Question 3:*
                     What are the effectiveness, comparative effectiveness, and harms of interventions for people at risk for grief disorders related to bereavement? a. 
                    *Timing:*
                     predeath, acute, or 6-12 months post loss, and more than 1 year post loss? b. Does effectiveness vary by patient characteristic or setting? *Key Question 4:*
                     What are the effectiveness, comparative effectiveness and harms of interventions for people diagnosed with grief-related disorders? a. Does effectiveness vary by patient characteristic or setting? PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and Setting) Eligibility Criteria
Element
Inclusion criteria
Exclusion criteriaPopulation
*KQ1:*
                             Children or adults
                             
                                *KQ2-3:*
                                 Children or adults who have experienced a human (including in utero) death of someone close to them or will do so in the near future (e.g., in a hospice setting) and who are at risk of being diagnosed with a grief disorder
                             
                             
                                *KQ4:*
                                 Children or adults diagnosed with a grief disorder (prolonged grief disorder, complicated grief, chronic grief disorder, persistent complex bereavement disorder) according to DSM (prolonged grief disorder) or ICD (ICD11 6B42, ICD10 F43.81, ICD9 309.0)
Studies on other forms than personal grief, such as community expressions of grief, public reactions to loss or trauma.Interventions
*KQ1:*
                             Screening strategy evaluation with screening tool
                             
                                *KQ2:*
                                 Diagnostic strategy evaluation, diagnostic or screening tool
                             
                             
                                *KQ3:*
                                 Interventions to prevent or treat grief disorder
                             
                             
                                *KQ4:*
                                 Interventions to treat grief disorders
*KQ1:*
                             Incidental or non-systematic identification of grief or reaction to loss.
                             
                                *KQ3:-4:*
                                 Interventions delivered by lay persons or non-healthcare professionals not applicable to a healthcare setting.Comparators
*KQ1:*
                             No screening approach, usual care, or an alternative screening approach
                             
                                *KQ2:*
                                 No tool, an alternative tool, concordance with grief disorder diagnosis
                             
                             
                                *KQ3:*
                                 No intervention, usual care, or an alternative intervention
                             
                             
                                *KQ4:*
                                 Usual care or an alternative intervention
*KQ1:*
                             No reference standard or method to detect the impact of screening.
                             
                                *KQ2:*
                                 No reference standard to determine the accuracy of the diagnostic tool.
                             
                             
                                *KQ3:-4:*
                                 No concurrent comparator.Outcomes
*KQ1:*
                             Immediate experience (patient experience, medicalizing grief, abnormalizing grief, feeling of pathologizing a normal process), screening accuracy (e.g., correctly diagnosed with grief disorder), and impact (e.g., delayed diagnosis, underdiagnosis, overdiagnosis, delayed treatment, undertreatment due to missed diagnosis, overtreatment)
                             
                                *KQ2:*
                                 Diagnostic accuracy (e.g., sensitivity, specificity, accuracy, area under the curve, positive predictive value, negative predictive value, false positives, false negatives, grief disorder identification) or impact (e.g., delayed diagnosis, underdiagnosis, overdiagnosis, effects of false positive test results, delayed treatment, undertreatment due to missed diagnosis, overtreatment)
                             
                             
                                *KQ3:*
                                 Grief symptoms, incidence of grief disorder, severity of grief disorder, any adverse events or unintended consequences of the intervention
                             
                             
                                *KQ4:*
                                 Grief symptoms, resolution of grief disorder diagnosis, physical or mental health, quality of life, functional status, patient experience, costs, any adverse events or unintended consequences of the intervention
Clinician or organizational barriers to, opinions on, preferences to, or uptake of screening, diagnosing, or treatment of grief.Timing
Any, no restrictions regarding the timing of the intervention or follow upSetting
Any settingStudy Design
*KQ1:-2:*
                             Screening and diagnosis impact analyses and diagnostic accuracy studies
                             
                                *KQ3:-4:*
                                 Randomized controlled trials (RCTs), clinical trials comparing two or more interventions, observational cohort studies comparing two or more intervention cohorts, controlled post-only studies, and case-control studies
*KQ1:-2:*
                             Descriptions without information on the impact or accuracy of the screening approach or tool performance.
                             
                                *KQ3:-4:*
                                 Studies without control group or concurrent group that does not receive the intervention or that receives a different intervention.Other limiters
Data published in English-language journal manuscript or trial records; relevant literature reviews will be retained for reference mining
Data only reported in abbreviated format (e.g., conference abstracts) and/or data only reported in non-English outlets.**Notes:**
                         DSM Diagnostic and Statistical Manual of Mental Disorders, ICD international classification of diseases, KQ key question.
 Dated: December 7, 2023. Marquita Cullom, Associate Director.


[FR Doc. 2023-27238 Filed 12-11-23; 8:45 am] BILLING CODE 4160-90-P